Study of a New Technique for Imaging Pancreatic Cancer

Korábbi kezelés

• Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
• Other on-going cancer therapy or investigational agents (except MVT-5873)
• Prior entry onto this protocol 3 or more times (e.g., subjects may enter this protocol and be imaged up to 3 times)

Más betegség

• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• History of anaphylactic reaction to human, or humanized, antibody
• Known history of HIV
• Psychiatric illness/social situations that would interfere with compliance with study requirements

Egyéb

• Pregnant or currently breast-feeding

• PART I : ESCALATION, EXPANSION, RE-ENTRY COHORTS:
• Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
  • PART II: PRE-SURGERY COHORT ONLY:
• Patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3)
• Patients scheduled referred to surgery or biopsy as standard of care for their pancreatic adenocarcinoma OR
• Patients with Intraductal papillary mucinous neoplasm (IPMN) referred to surgery or biopsy as standard of care.
  • The suspicion for pancreatic carcinoma and decision for surgery or biopsy will be based on review of imaging and clinical findings in the disease management team discussion including surgeon and radiologist.
  • PART I and II:
• Signed, informed consent
• Age 18 or more years
• At least one lesion by CT or MRI ≥ 2 cm, unless determine otherwise for pre-surgery cohort subjects
• CA19-9 serum level:
  • For Part I: >ULN or CA19-9 positive biopsy (optional);
  • For Part II ( presurgical cohort): CA19-9 serum level (normal or high levels are allowed) or CA19-9 positive biopsy (optional)
• ECOG performance status of 0 to 2
• Adequate laboratory parameters including:
  • Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
  • Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)
  • Platelet count >75,000/ mm\^3
  • AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN
  • Total bilirubin ≤1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal
  • Creatinine (serum or plasma) ≤ 1.5 x ULN or eGFR>50 mL/min
  • PART I: ESCALATION, EXPANSION, RE-ENTRY COHORTS:
• Willingness to participate in collection of pharmacokinetic samples